Evaluation of Clareon Vivity/Vivity Toric

NCT ID: NCT05852470

Last Updated: 2024-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2023-10-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aphakia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors will be masked to the IOLs that have been previously implanted in the subject until the end of the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clareon Vivity/Vivity Toric

Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation

Group Type EXPERIMENTAL

Clareon Vivity/Vivity Toric Extended Vision IOL

Intervention Type DEVICE

Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Clareon Monofocal/Clareon Toric

Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation

Group Type ACTIVE_COMPARATOR

Clareon Monofocal/Clareon Toric IOL

Intervention Type DEVICE

Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clareon Vivity/Vivity Toric Extended Vision IOL

Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Intervention Type DEVICE

Clareon Monofocal/Clareon Toric IOL

Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6 Clareon Vivity™ Extended Vision Hydrophobic IOL Clareon Vivity™ Toric Extended Vision Hydrophobic IOL SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0) Clareon™ Aspheric Hydrophobic Acrylic IOL Clareon™ Toric Aspheric Hydrophobic Acrylic IOL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Understand and sign an approved Informed Consent form
* Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.

Exclusion Criteria

* History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
* Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
* Clinically significant PCO (posterior capsule opacification) affecting vision.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Lead, Surgical CRD

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wolstan Goldberg Eye Associates

Torrance, California, United States

Site Status

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, United States

Site Status

Grosinger, Spigelman & Grey Eye Surgeons, P.C.

Bloomfield Hills, Michigan, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Eye Care Specialists

Kingston, Pennsylvania, United States

Site Status

Carolina Eyecare Physicians LLC

Mt. Pleasant, South Carolina, United States

Site Status

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ILE632-C002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clareon Toric Study (T2-T9)
NCT06285695 ACTIVE_NOT_RECRUITING NA